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Devices Diagnostics FDA

 News Release - June 9, 2022

Scopio Labs Awarded FDA Clearance for High Throughput Hematology Digital Cell Morphology Platform, Replacing Microscopes with Digitization

This is the company's second FDA clearance, broadening its suite of fully digital platforms to cater to all lab sizes and networks

TEL AVIV, Israel, June 9, 2022 -- (Healthcare Sales & Marketing Network) -- Scopio Labs, a medtech company that develops AI-powered diagnostic platforms for earlier and more accurate detection of cancers, infections, and other diseases, announced today that its ground-breaking X100HT device with Peripheral Blood Smear (PBS) Application has received U.S. FDA 510(k) clearance. Coupling high throughput capabilities with the highest resolution for hematological analysis, the X100HT caters to major medical facilities and labs across the world.

With the increasing worldwide prevalence of hematological disorders and malignancies, the accuracy and timeliness of PBS results are critically important for early diagnosis and effective treatment initiation. The peripheral blood smear review is a powerful diagnostic tool that provides rapid, reliable access to information about a variety of disorders such as blood related cancers, anemia, infections, and allergies. The majority of these tests are performed manually, but Scopio's disruptive Full-Field™ PBS morphology solution completely eliminates the need for additional manual microscopic examination.

In manual microscopy, users must choose between a large field of view or high resolution. Scopio's devices eliminate that tradeoff completely, capturing large scan areas at 100X magnification. Holding 30 slides and processing up to 40 samples an hour, Scopio's X100HT can meet the high throughput requirements of large hospitals and labs, while fully supporting remote review capabilities, enabling a new subfield of telehematology. Hospital and lab networks can now operate seamlessly across multiple facilities of all sizes, with workload balancing, remote consultations, addressing personnel shortages and more.

"We're excited to expand our suite of fully digital AI-powered diagnostic platforms to accelerate PBS analysis, improve consistency of results, and reduce review time," said Erez Naaman, CTO and Co-Founder of Scopio Labs. "At Scopio, we are determined to usher in the digital revolution to laboratory medicine. Our devices offer complete remote capabilities for real-time diagnosis and treatment decisions, allowing experts to review, collaborate, and consult from anywhere, and at any time, using our AI-powered applications."

As affirmed by the American Society for Clinical Laboratory Science, there is a critical shortage of medical laboratory professionals. Aiming to overcome these barriers, Scopio delivers end to end digital transformation of the lab process for Full-Field™ PBS review of white blood cells, red blood cells, and platelet estimation. The results of every assessment (including images, annotations and flagged abnormalities) are automatically documented in a standardized digital report and seamlessly shared across the continuum of care.

As the first Full-Field™ digital imaging and AI-powered analysis platform, Scopio provides a solution to the laboratory workforce shortage by reaching a level of workflow efficiency and traceability that has never been possible before.

About Scopio

Scopio Labs is transforming cell morphology analysis, offering a suite of fully digital diagnostic applications and platforms that drastically enhance clinical workflows and enable faster, earlier, and more accurate detection and diagnosis of disease, expediting patients' access to life-saving treatments.

Solving the tradeoff between field-of-view and resolution, Scopio enables labs to assess and analyze cell morphology at unprecedented scale and depth. The company's combination of high-resolution imaging and an AI-powered decision support system makes the diagnosis process more efficient and consistent across the continuum of care. More AI solutions are under development, including for bone marrow aspirates (BMA), the first application that enables a complete digital workflow for a BMA review.

Scopio Labs' FDA-cleared, CE-marked Full-Field Peripheral Blood Smear applications are in full commercial use across the U.S. and Europe. To learn more, visit https://scopiolabs.com/.


Source: Scopio Labs

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